Method of and system for associating an electronic signature with an electronic record

ABSTRACT

A method of and system for associating an electronic signature with an electronic record in a computer system. In one embodiment the method comprises allowing a user to define an event that, upon occurrence, generates an electronic record that requires an electronic signature; allowing a user to define the fields stored in the electronic record; allowing a user to generate a map that maps data from underlying database tables to at least some of the fields defined for the electronic record; allowing a user to define a layout for displaying data in the electronic record on a computer display when an electronic signature for the data record is collected; allowing a user to identify a signatory approver for the electronic record; generating the electronic record and displaying the electronic record to the signatory approver according to the defined layout in response to the occurrence of the event; receiving an electronic signature from the signatory approver; and associating the electronic signature with the electronic record. Some embodiments further comprise verifying the electronic signature prior to associating the signature with the electronic record.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/523,221, entitled eSIGNATURES AND eRECORDS SYSTEM, by SrikanthKarimisetty et al., filed Nov. 18, 2003, the disclosure of which isincorporated herein by reference. This application is also being filedconcurrently with U.S. application Ser. No. 10/731,673, entitled METHODOF AN SYSTEM FOR SEARCHING UNSTRUCTURED DATA STORED IN A DATABASE, bySrikanth Karimisetty et al.; and with U.S. application Ser. No.10/731,604, entitled METHOD OF AND SYSTEM FOR CREATING QUERIES THATOPERATE ON UNSTRUCTURED DATA STORED IN A DATABASE, by SrikanthKarimisetty et al. and with U.S. application Ser. No. 10/731,655,entitled METHOD OF AND SYSTEM FOR COMMITTING A TRANSACTION TO ADATABASE, by Srikanth Karimisetty et al.; and with U.S. application Ser.No. 10/731,299, entitled METHOD OF AND SYSTEM FOR COLLECTING ANELECTRONIC SIGNATURE FOR AN ELECTRONIC RECORD STORED IN A DATABASE, bySrikanth Karimisetty et al.; and with U.S. application Ser. No.10/731,623, entitled METHOD OF AND SYSTEM FOR DETERMINING IF ANELECTRONIC SIGNATURE IS NECESSARY IN ORDER TO COMMIT A TRANSACTION TO ADATABASE, by Srinivasulu Puri et al. the disclosures of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to a method of and system for securelystoring and accessing electronic records, capturing electronicsignatures and securely associating captured electronic signatures withcorresponding electronic records. Embodiments of the invention areuseful to a variety of companies in a variety of different industriesand some embodiments are particularly useful in helping pharmaceutical,medical device, and food manufacturing companies ensure compliance withGood Manufacturing Practice regulations (GMPs) as the companies produceand test products that people/animals use.

Historically, organizations manually tracked huge volumes of data fromday-to-day business transactions in hard copy format. The requirementsof maintaining such hard copies differed from one organization toanother and in some instances depended in part on government ledmandates for standard operating procedures. For example, if apharmaceutical company based in the United States wanted to maintainrecords documenting the creation of a new drug from its inception to theclinical test stage it had to maintain a huge volume of paper basedrecords in accordance with Food and Drug Administration (FDA)regulations. It can be appreciated that searches through such recordsfor particular pieces of information could be a time consuming activity.It can also be appreciated that if access to particular classes of thehard copy records needs to be controlled for security reasons,physically separating the confidential documents from the regular onesbecomes a highly tedious job.

Accordingly, many organizations have switched from paper-based recordssystems to electronic-based records (sometime referred to herein aseRecords). With the advent of eRecords, all business transaction recordsof an organization are stored electronically in a common data store of abusiness application software system. Some systems that store electronicrecords use XML (extensible Markup Language) technology because XML isan open, extensible and nonproprietary format.

While storing XML-based eRecords may significantly reduce paperworkpreviously required, the ability to efficiently search all existingeRecords is still a challenging task due to the flexible structure ofthe XML records themselves. The flexible XML structure of eRecords alsomakes restricting access to certain XML records in an organization achallenging proposition.

In addition to these challenges, eRecord systems must also be able tosupport the ability to electronically sign the electronic documents,ensuring that the appropriate personnel have reviewed and approved them.GMPs generally require signatures on transactions that affect productquality. Companies may also require signatures when moving the custodyof goods from one location or department to another or when movingresponsibility for manufacturing from one department to another. Ingeneral, wherever companies have generally required a paper signature inthe past for such transactions, a signature is needed on the electronicdocument that replaces it once the company has made the switch from apaper-based world to electronic documents.

Accordingly, systems and methods for addressing the challenges in anelectronic-based records system and systems and methods for handlingelectronic signature requirements in an electronic-based records systemare needed.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the invention provide an improved electronic-basedrecords system that addresses the challenges discussed above.

According to one embodiment of the invention, a method of collecting anelectronic signature for an electronic record stored in a database isdisclosed. The method comprises automatically creating an electronicrecord from data stored in a plurality of different database tables inresponse to the occurrence of a predetermined event; storing an instanceof the electronic record in a common repository of electronic recordsthat provides an audit trail that cannot be altered or disabled by usersof the system; executing a rule associated with the electronic record todetermine whether an electronic signature is required to connote reviewand/or approval of the electronic record; and if execution of the ruleresults in a determination that an electronic signature is required,marking the instance of the electronic record as unsigned and initiatinga request to collect the required electronic signature. In oneparticular implementation of this embodiment, the electronic record isstored in a common repository of electronic records that provides anaudit trail that cannot be altered or disabled by users of the database.In some implementations the electronic record is stored as unstructureddata in a character large object (CLOB) format and the unstructured datacomprises a well-formed XML document stored within a column of a tablestored in the database.

In another embodiment, a method of associating an electronic signaturewith an electronic record is disclosed. The method comprises allowing auser to define an event that, upon occurrence, generates an electronicrecord that requires an electronic signature; allowing a user to definethe fields stored in the electronic record; allowing a user to generatea map that maps data from underlying database tables to at least some ofthe fields defined for the electronic record; allowing a user to definea layout for displaying data in the electronic record on a computerdisplay when an electronic signature for the data record is collected;allowing a user to identify a signatory approver for the electronicrecord; in response to the occurrence of the event, generating theelectronic record and displaying the electronic record to the signatoryapprover according to the defined layout; receiving an electronicsignature from the signatory approver; and associating the electronicsignature with the electronic record. In some implementations of thisembodiment the method further comprises verifying the electronicsignature prior to associating the signature with the electronic record.

In another embodiment, a method of committing a transaction to adatabase is provided. The method comprises initiating a databasetransaction; creating an electronic record that includes transactiondata from the database transaction; executing a rule associated with therecord to determine whether an electronic signature is required toconnote review and/or approval of the electronic record, and ifexecution of the rule results in a determination that an electronicsignature is required, requesting the electronic signature prior tocommitting the transaction to the database.

Another embodiment of the invention pertains to a method of searchingunstructured data stored in a database. The method comprises storing aplurality of electronic records, each comprising unstructured datastored in a character large-object (CLOB) format in a column of a tableof the database, in a common repository of electronic records in thedatabase that provides an audit trail that cannot be altered or disabledby users of the system; creating a security protocol that protects theelectronic records against unauthorized access; creating a querydesigned to identify electronic records in the database that meetcriteria designated in the query; prior to executing the query,modifying the query in accordance with the security protocol to create amodified query; running the modified query against the unstructureddata. In some implementations of these embodiments, access to records inthe database is automatically granted unless security protocol restrictssuch access and the security protocol comprises a plurality of securityrules that restricts access to the records within the database. In otherimplementations, access to records in the database is automaticallydenied unless security protocol grants such access and the securityprotocol comprises a plurality of security rules that grant access tothe record within the database. In one particular implementation of thisembodiment, the database is a common repository of electronic recordsthat are generated from multiple data sources. In some implementationsthe unstructured data comprises a well-formed XML document stored withina column of a table stored in the database.

Another embodiment of the invention pertains to a method of searchingunstructured data stored in a database where the method comprisingstoring unstructured data in a column of a database table; allowing auser to identify elements in the unstructured data as indexed elements;creating an intermediate index into the unstructured data from theidentified elements; and allowing a user to create queries on theunstructured data using the indexed elements. In some implementations ofthis embodiment the unstructured data comprises a well-formed XMLdocument stored within a column of a database table. Also, in someimplementations the unstructured data is part of an electronic recordstored in a common repository of electronic records that provides anaudit trail that cannot be altered or disabled by users of the database.

In still another embodiment of the invention, a method of intercepting atransaction instantiated by a database application to determine if anelectronic signature is necessary to commit the transaction to thedatabase is disclosed. The method comprises calling an applicationprogram interface to raise an event in response to a triggering actiongenerated by the database application; initiating a workflow processthat executes a rule to determine if an electronic signature is requiredto approve the transaction; and if execution of the rule results in adetermination that an electronic signature is required for thetransaction, instantiating a signature collection process. In someimplementations of this embodiment the method further comprisesobtaining an electronic signature in response to the signaturecollection process and thereafter, verifying the electronic signatureand updating a filed of the electronic record to indicate a validsignature was collected if the electronic signature is verified.

Other embodiments of the invention include computer systems comprising aprocessor, a database and a computer-readable memory coupled to theprocessor, where the computer-readable memory is configured to store acomputer program that allows the processor to perform the methodsdescribed herein. And still additional embodiments of the invention aredirected to computer programs stored on computer-readable storagemediums where the computer program comprises code for carrying out themethods described herein.

These and other embodiments of the invention along with many of itsadvantages and features are described in more detail in conjunction withthe text below and the attached figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a simplified block diagram of computer system 10 for managingelectronic records and electronic signatures according to one embodimentof the present invention;

FIG. 1B is a logical block diagram of system 10 shown in FIG. 1Aaccording to one embodiment of the present invention;

FIG. 2 illustrates one example of the data format used to storeelectronic records in evidence store 30 shown in FIG. 1B;

FIG. 3 is a more detailed block diagram of the system shown in FIG. 1B;

FIG. 4 is a flow chart that depicts various steps involved with settingup system 10 to associate electronic signatures with particularelectronic records according to one embodiment of the invention;

FIG. 5 illustrates one example of an input form that can be completed bya user to enter information related to an event;

FIG. 6 illustrates one example of an approval matrix that can be definedduring the process set forth in FIG. 4;

FIGS. 7, 8 and 13-15 are examples of computer display screen shotsgenerated by a graphical user interface to assist a user in creatingindexed elements that can be used to create security rules and querieson electronic records stored in evidence store 30 according to oneembodiment of the invention;

FIG. 9 illustrates one example of database tables that can be used totrack indexed elements as part of index 33 shown in FIG. 1B according toone embodiment of the invention;

FIGS. 10, 12 and 20 are examples of computer display screen shotsgenerated by a graphical user interface to assist a user in creatingsecurity rules according to one embodiment of the invention;

FIG. 11 illustrates one example of a database table used to tracksecurity rules according to one embodiment of the invention; and

FIGS. 13, 14, 16-19 and 21 are examples of computer display screen shotsgenerated by a graphical user interface to assist a user in creatingqueries according to one embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

In some industries a process can be viewed as a pre-defined method ofproducing goods. Such processes typically include several events andsub-events where an event is an operation or group of operations to beperformed to accomplish a task. The execution of events such as theseare time, material and resource sensitive. Organizations often desire totrack the execution of events to make sure that the event has beencompleted as required by the process that the event is part of. Toachieve this, checkpoints can be implemented at each event or sub-eventto keep track of information such as: what is the event? who initiatedthe event? when was it initiated? who authorized the event? when was itcompleted? who confirmed the event completion? etc.

This information can be captured electronically and stored in a databaseso that it can be subsequently retrieved using query based userinterfaces or reports. Embodiments of the invention allow a company orother organization to compile and store electronic records that trackvarious events defined by the company. Embodiments also allow electronicsignatures to be captured and linked with their respective electronicdata records so that the electronic signatures to be kept as part of adata record's audit trail. As used herein an “electronic signature”(sometimes referred to as an “eSignature”) is a computer datacompilation of any symbol or series of symbols executed, adopted orauthorized by an individual to be the legally binding equivalent of theindividual's handwritten signature. An electronic signature contains atleast two distinct components: an ID and a password. An electronicsignature connotes authorship, review and approval of data and can bedisplayed and printed with signed electronic records. A “digitalsignature” is an electronic signature based upon cryptographic methodsof originator authentication, computer by using a set of rules and a setof parameters such that the identify of the signer and the integrity ofthe data can be verified.

Some embodiments of the invention operate in a closed system. As usedherein, a “closed system” is an environment in which system access iscontrolled by persons who are responsible for the content of electronicrecords that are on the system. In contrast, an open system is anenvironment in which system access is not controlled by persons who areresponsible for the content of electronic records that are on thesystem. An example of an open system is an online trading community.

FIG. 1A is a simplified block diagram of computer system 10 for storingand updating electronic records, including electronic records associatedwith events, according to one embodiment of the present invention. Asused herein an electronic record (sometimes referred to as an “eRecord”)is a defined set of data captured from a moment in time by software. Thedata may include any combination of text, graphics, audio, pictorial orother information represented in digital form that is created, modified,maintained, archived, retrieved or distributed by a computer system.Typically, some or all of the data is captured to the electronic recordfrom multiple database tables. System 10 tracks electronic records in amanner such that recorded changes to the records do not obscurepreviously recorded information.

One example of electronic records includes records maintained bypharmaceutical, medical device, food manufacturing and other companiesto ensure compliance with Good Manufacturing Practices (GMPs) and 21 CFRPart 11. GMPs are regulations that describe the methods, equipment,facilities, and controls required for producing human pharmaceuticalproducts, veterinary products, biologically derived products, medicaldevices and processed food among other items. 21 CFR Part 11 establishesa uniform, baseline standard by which the Food and Drug Administration(FDA) will consider electronic records to be equivalent to paper recordsand electronic signatures to be equivalent to handwritten signatures.The baseline standard provides an enforceable mechanism for acceptingelectronic records and their associated signatures and provides a levelof confidence that electronic records maintained in accordance with therule will be of high integrity. While specific examples of the inventionare often described below in conjunction with maintaining electronicrecords and signatures in accordance with GMPs and 21 CFR Part 11, it isto be understood that system 10 can be used to store and updateelectronic records in other industries that do not require conformanceto GMPs and/or conformance to 21 CFR Part 11.

As shown in FIG. 1A, computer system 10 includes one or more processors1 that communicate with a number of peripheral devices via a bussubsystem 2. These peripheral devices may include a storage subsystem 3,comprising a memory subsystem 4 and a file storage subsystem 5, userinterface input devices 6, user interface output devices 7, and anetwork interface subsystem 8. The input and output devices allow userinteraction with computer system 10. A user may be a human user, adevice, a process, another computer, and the like. Network interfacesubsystem 8 provides an interface to other computer systems andcommunication networks including communication network 9, which may be,for example, a local area network (LAN), wide area network (WAN) and/orpublic network such as the Internet. While not shown in FIG. 1A, in someembodiments network interface subsystem 8 is connected to one or morenetwork server computers, for example by a LAN within network 9. Theserver computers connect computer system 10 to the Internet and provideappropriate security functions such as a firewall and the like.

Bus subsystem 2 provides a mechanism for letting the various componentsand subsystems of computer system 10 communicate with each other asintended. The various subsystems and components of computer system 10need not be at the same physical location but may be distributed atvarious locations within network 9. Although bus subsystem 2 is shownschematically as a single bus, alternative embodiments of the bussubsystem may utilize multiple buses.

User interface input devices 6 may include a keyboard, printing devices,a mouse, trackball, touchpad, a graphics tablet, a scanner, a barcodescanner, a touch screen incorporated into the display, audio inputdevices such as voice recognition systems, microphones, and other typesof input devices. User interface output devices 7 may include a displaysubsystem, a printer, a fax machine, or non-visual displays such asaudio output devices. The display subsystem may be a cathode ray tube(CRT), a flat-panel device such as a liquid crystal display (LCD), or aprojection device. In general, use of the term “output device” isintended to include all possible types of devices and ways to outputinformation from computer system 10.

Storage subsystem 3 may be configured to store the basic programming anddata constructs that provide the functionality of the computer systemand of the present invention. For example, according to an embodiment ofthe present invention, software modules implementing the functionalityof the present invention may be stored in storage subsystem 3. Thesesoftware modules may be executed by processor(s) 1. In a distributedenvironment, portions of the software modules may be stored on aplurality of computer systems and executed by processors of theplurality of computer systems. Storage subsystem 3 may also provide arepository for storing the various databases and files used by thepresent invention including evidence store 30 and database 34 shown inand discussed with respect to FIG. 1B.

Memory subsystem 4 may include a number of memories including a mainrandom access memory (RAM) 4 a for storage of instructions and dataduring program execution (e.g., execution of an instance of a softwaresystem for a database) and a read only memory (ROM) 4 b in which fixedinstructions are stored. File storage subsystem 5 provides persistent(non-volatile) storage for program and data files, and may include oneor more hard disk drives, appropriate removable media cartridges, andother like storage media. One or more of the storage devices may belocated at remote locations on other connected computers.

Computer system 10 itself can be of varying types including a personalcomputer, a portable computer, a workstation or any other dataprocessing system. Due to the ever-changing nature of computers andnetworks, the description of computer system 10 depicted in FIG. 1A isintended only as a specific example for purposes of illustrating oneembodiment of the computer system. Many other configurations of acomputer system are possible having more or fewer components than thecomputer system depicted in FIG. 1A. For example, several othersubsystems may be included in computer system 10 depending upon thefunctions performed by system 10.

FIG. 1B is a logical block diagram of computer system 10 according toone embodiment of the invention. As shown in FIG. 1B, system 10 includesa number of different logical components that are hosted on a computersystem, which may include a number of distributed server systems andclient systems. The logical components, which for illustrative purposesare shown as electronic record and electronic signature (ERES) setupcomponent 20, ERES framework engine 22, security rule engine 24 andquery engine 26 are executed by users 12 to allow system 10 to create,modify, maintain and search electronic records.

System 10 also includes an evidence store 30, a user interface 32 thatallows users to interact with the logical components and the evidencestore and a database 34. In some embodiments user interface 32 alsoallows users to interact with one or more business applications 36 thathave the capability to invoke ERES engine 32 to generate and sendelectronic records to evidence store 30 as described in detail below.Business applications 36 can be any application used by an organizationthat accesses electronic records and/or allows users to electronicallysign electronic records. Suitable examples of a business application 36include any of the more than 160 software modules for financialmanagement, supply chain management, manufacturing, project systems,human resources and customer relationship management that integrate intothe Oracle Applications Suite developed and marketed by Oracle, assigneeof the present invention.

Database 34 is a collection of information organized in a way thatsystem 10 can quickly select desired pieces of data. Database 34includes a database management system that enables data to be stored,modified and extracted from the database. The database management systemwithin database 34 provides a database application program interface(API) through which database applications, such as business application36, can access data managed by the database. Data managed by database 34can be stored in relational tables that can be queried using anydatabase language supported by the database including, for example, thepopular structured query language (SQL).

In one embodiment, database 34 also allows applications to access datastored in the database by translating operating system I/O commands intodatabase commands and/or through an alternative API referred to hereinas the database file API. The database file API supports file operationssimilar to those supported by conventional OS file APIs but, unlike OSfile APIs, incorporates the database API concept of transactions. Thatis, the database file API allows applications to specify that a set offile operations are to be performed as an atomic unit.

The database file API commands are translated to database commands by adatabase file server in the database management system. According to oneembodiment database file server is object oriented. Thus, routinessupplied by the database file server are invoked by instantiating anobject and calling methods associated with the object. In oneimplementation the database file server defines a “transaction” objectclass that includes the following methods: insert, save, delete, update,commit and roll-back. The database file API provides an interface thatallows external entities, such as application 36, to instantiate and usethe transaction object class.

The methods invoked on a single transaction object may involve multiplefile operations. If one of the operations fails during the instantiationof the transaction object, a roll-back process is invoked that undoesthe changes made by the transaction object. In one particularembodiment, database 34 is a collection of software programs and/orcomponents available from Oracle, such as Oracle Database. It is to beunderstood that database 34 can be any system, however, that organizesdata in a manner that allows system 10 to quickly select desired pieces.It is also to be understood that components 20-36 are logicallyrepresented in FIG. 1B and that system 10 can include fewer, more ordifferently arranged logical components.

Evidence store 30 is a secure, common repository of electronic recordsthat can be generated from multiple data sources, such as multipledatabase tables within database 34, in response to the occurrence ofpredefined events. As a single repository, all records that need to bekept for compliance with a companies business objectives (e.g.,compliance with 21 CFR Part 11) are kept together. Thus, in order tosearch the companies electronic records, there is no need to searchmultiple databases on multiple servers.

Generally, data is added to evidence store 30 but never deleted.Individual eRecords can be deleted in one sense (e.g., replaced by anewer record) but the original, deleted eRecord still remains part ofthe evidence store and can be retrieved if desired. In this manner, theevidence store is a secure database that maintains an audit trail forall records that are added, changed or deleted from the evidence store.In doing so, system 10 tracks for each eRecord when a change was made,who made the change and creates a record of the before and afterinformation. The audit trail cannot be altered or disabled by users ofthe system and allows the evidence store to be reconstructed back to anygiven date and time.

Electronic records stored in evidence store 30 include unstructureddata, such as data stored in character large object (CLOB) format, inone or more columns of a database table. In one embodiment theunstructured data includes a well-formed XML document stored within asingle table or column of the database. While each XML document adheresto a structure (e.g., a particular DTD) and in one sense is thusstructured data, the database column the XML document is stored in isunstructured in the sense that it can store XML data that adheres to avariety of DTDs and thus is not limited to storing data that adheres toa particular structure. The XML format provides portability andlongevity to the data captured in electronic records. The XML documentmay include numerous proprietary and/or application-specific formats andis thus a highly flexible structure.

In one embodiment, evidence store 30 is part of database 34 and includesfour different database tables that are separate from the databasetables used to support the one or more business applications 36 andother functions of system 10. These four database tables include a tablefor storing eRecord details, a table for storing eRecord parameters, atable for storing eSignature details and a table for storing eSignatureparameters. Separate tables are used to store eSignature and eRecordparameters because the parameters can be different for differenteRecords and their number can also vary significantly. The separatetables maintain the parameters as name-value pairs so that additionalcolumns in the main tables do not need to be added-an approach that isespecially beneficial when it is not known how many parameters mayexist.

FIG. 2 illustrates one example of database table formats in whicheRecord details (table 30 a) and eSignature details (table 30 b) can bestored in evidence store 30 according to an embodiment of the invention.As shown in FIG. 2, table 30 a includes a column for a primary key thatis unique to each eRecord generated, a column that stores well-formedXML data generated for the record as unstructured data in CLOB format, aCLOB column that contains a copy of the XML data as it is displayed tousers of system 10 and various audit columns including columns for atimestamp when the eRecord was requested, a time stamp of when creationof the eRecord was initiated, the time zone the eRecord was created in,the status of the eRecord (e.g., pending, complete, error), the name ofthe entity or agent that requested creation of the eRecord, the eventthat the eRecord was created for, a field that tracks the number oftimes the eRecord was printed or viewed and information tracking whocreated and last updated the eRecord. Table 30 b stores a record of eacheSignature requested and includes a primary key of a signature ID, adocument ID that links the signature record to the eRecord (e.g., theprimary key of the eRecord), the name of the user (signee) being askedto sign the eRecord, the signee's response, the date and time theeRecord was signed, the time zone that it was signed in and the statusof the eSignature (e.g., pending, complete, rejected, error). Thesignee's response may include, for example, details like the signingreason (whether it's a rework or first attempt), signer type (author,approver, reviewer, etc.).

Reference is now made to FIG. 3, which is more detailed logic-orientedblock diagram illustrating the interaction between selected logicalcomponents of system 10 in creating, updating and accessing data in theERES evidence store according to one embodiment of the invention. Thefunction-oriented diagram of FIG. 3 logically divides system 10 intofour separate functions including, from left to right: eRecord andeSignature setup, eRecord and eSignature processing, eRecord andeSignature security features, and eRecord and eSignature query featuresthat operate to create, maintain and access evidence store 30. Forconvenience, each of these functional aspects of system 10 is discussedin more detail below.

Electronic Record and Electronic Signature Setup

Setup component 20 of system 10 allows a user to perform all the variousfunctions that are required to integrate electronic record tracking andelectronic signature capture alone or in conjunction with a businessapplication 36. In the embodiment depicted in FIG. 3, setup component 20includes multiple subcomponents including a business event setupcomponent 20 a, an eRecord content setup component 20 b and aneSignature rule setup component 20 c.

Business event setup component 20 a allows users to define events 40that, upon occurrence of the event, trigger an action by anothercomponent of system 10, such as an action by ERES engine 22. As usedherein, an event 40 is an occurrence in a computer application orprogram, such as an Internet or intranet application, that issignificant to other objects in system 10 or to external agents. Eventsetup component 20 a allows users to enable eRecord capture and/oreSignature collection upon the occurrence of the defined event bydefining an ERES subscription 41 to the event. This can be done, forexample, by storing two Boolean flags for each event: one flag denotingwhether or not the event triggers generation of an eRecord and the otherflag denoting whether or not the event triggers capture of aneSignature.

eRecord content setup component 20 b allows users to define data typedefinitions (DTDs) 42, define mappings 43 between XML records andentries in database tables and create XSL (eXtensible StylesheetLanguage) style sheets 44 that define layout settings for formatting andpresenting eRecords to users. System 10 can store any defineddatabase-to-XML mappings in a data repository, such as database 34 shownin FIG. 1B.

eSignature rule setup component 20 c allows users to define rules 45 andan approval hierarchy 46 (approval matrix) for electronic signatureevents as well as store rule specific attributes such as the type ofstyle sheet to be applied for a particular rule. Rules that can bedefined by component 20 c include rules related to how long system 10will wait for obtaining signatures, whether multiple attempts to collectsignatures will be made if necessary and, if so, the various timingissues associated with sending multiple attempts or reminder messages.Also in one embodiment of the invention, component 20 c allows a user toselect one of two distinct methods (rules) by which a required signatureis collected: inline signature collection and offline (or deferred)signature collection. Details on these two collection methods arediscussed later in the application and they are sometimes referred to assynchronous and asynchronous signature collection, respectively.

System 10 is typically set up by one or more users working with thevarious components of setup component 20 to define the various eventssystem 10 tracks as well as the rules associated with tracking suchevents prior to using the system to capture, store and update electronicrecords. FIG. 4 is a flow chart that depicts various steps involved withsetting up system 10 to associate electronic signatures with particularelectronic records according to one embodiment of the invention. Thesetup sequence includes three primary steps as shown in FIG. 4including: defining events (step 50), defining event metadata (step 60)and defining a signature approval matrix (step 70). While these stepsare depicted sequentially in FIG. 4, it is to be understood that thevarious setup steps may be performed partly or entirely in parallel andthat they may occur in an order different than the order depicted in theFIG. 4.

As shown in FIG. 4, event definition step 50 includes a first substep 52of defining the events 40 that require electronic signatures. In step 52a user selects a unique name for each such event defined. The event canthen be referenced across the framework of system 10 and outside of itby its chosen name. A user needs to know (or at least be able toidentify) the event name in order to call the event with an appropriateapplication program interface (API) from one of business applications36. In one embodiment the event name is a compound structure ofidentifiers separated by periods (.) as follows:

-   -   “oracle.apps.<product>.<component>.<object>.<event>”        where such a format allows users to organize the events defined        into a classification hierarchy.

FIG. 5 illustrates one example of an input form 80 that can be completedby a user to enter information related to an event. As shown in FIG. 5,form 80 includes a field 81 to enter the event name, a field 82 thatallows a user to select a name by which the event will be displayed inreports, a field 83 where a brief description of the event may beentered a field 84 that contains a status (e.g., enabled, disabled) ofthe event and a field 85 that indicates the application, such as abusiness application 36, to which the event belongs.

Once an event 40 is entered into the system by, for example, completingform 80 and selecting submit icon 86 shown in FIG. 5, a user can createa subscription 41 to the event by defining a triggering condition (FIG.4, step 54) which evokes the event and specifying the processing thatoccurs when the event is evoked (i.e., when the triggering is met). Thespecified processing may include calling and executing a piece of codeto perform a function and/or sending a message to a workflow process orother agent. A single event can have multiple subscriptions associatedwith it in which case the subscriptions are assigned a priority levelthat determines the order of execution. In one particular embodiment thepriority is set by a phase number stored in a column of a database tablewhere lower phase number subscriptions are performed or initiated priorto higher phase number subscriptions.

One event subscription that can be defined by component 20 a is therequirement for obtaining an electronic signature on an electronicrecord associated with the event (FIG. 4, step 56). A rule functioncreated by a user with eSignature setup component 20 c is associatedwith the subscription. The rule function determines if an eSignature isrequired and generates a snapshot of the data to be signed. The snapshotcan be generated as an XML document in the rule function and displayedto required signees as dictated by XSL style sheet 44 defined in step66.

System 10 can implement two types of eSignatures collection: synchronous(or inline collection) and asynchronous (or deferred collection). In oneembodiment the phase of the eSignature subscription determines if thesubscription is synchronous or not. For a synchronous signaturesubscription, the phase should be set to carry out eSignature collectionas the initial action (e.g., by using the lowest possible phase number)to make sure that the eSignature subscription is the first subscriptionexecuted when an event occurs. In one embodiment, an asynchronoussignature subscription can be created by setting the phase number abovea phase number that represents a predetermined limit on the number ofpossible synchronous subscriptions. In other embodiments thesynchronous/asynchronous nature of individual subscriptions can be setusing other techniques, such as, for example, storing a Booleanattribute for each subscription.

Asynchronous signature collection allows system 10 to collect signatureswhen the signature does not need to be obtained immediately, thesigner(s) are not in the same physical location or are otherwise notimmediately available at the time of signature request or there are oneor more items that the signer must verify prior to signing that wouldcreate a time lag between receipt of the signature request and theresponse. Asynchronous signature collection can be implemented withemail or another messaging system. In contrast, inline signaturecollection allows system 10 to capture eSignatures when the signatureneeds to be captured immediately so as to not delay further processing.In one embodiment an inline signature collection process creates apop-up window on the computer screen that displays the informationcaptured in the eRecord for the signer to review. The signer must thenreview and sign the eRecord before further processing associated withthe eRecord may occur.

Referring back to FIG. 4, the step of defining event metadata (step 60)includes defining a document type definition (DTD) 42 for each event 40created in step 52 (step 62). DTD 42 determines the XML representationof all data that needs to be captured by the system for a particularevent. The DTD can be defined in plain ASCII format using a text editorsuch as Notepad. The defined DTD 42 is then used in step 64 to map data,including data stored in database tables, to the event. Each event hascertain database entities (objects) and attributes associated with itwhich need to be monitored and captured during event execution. Eventdata can span multiple entities.

Step 66 allows a user to decide what information in the DTD should bepresented to a signee as well as how the information will be displayedwhen a signature is requested by an event by allowing the user to createan appropriate XSL style sheet 44. In step 68 DTD 42, XML mappings 43and XSL style sheet 44 created in steps 62, 64 and 66, respectively, arestored in a computer-readable medium, such as a durable storage deviceused to store records for database 34 shown in FIG. 1.

eSignature rule setup component 44 allows users to define a signatureapproval matrix (step 70). The matrix includes rules that determine whenan eSignature is required and/or when an eRecord is generated and if anapproval is necessary, the identify of the necessary approver orapproval group. Component 44 allows the matrix to define a singleapprover, multiple approvers where approval of each approver isnecessary or a group of approvers where approval of only a subset of thegroup is necessary.

FIG. 6 illustrates one example of an approval matrix 90 that can bedefined in step 72. Matrix 90 includes two rules 91 and 92 identified inthe matrix as separate rows. Each rule has an associated attribute 93and approver list 94. The attributes 93 used in matrix 90 includewhether or not an eRecord is generated, whether or not an eSignature isrequired and if so, the style sheet used to present data for review tothe approver. Rule 91 is executed if an event occurs at Plant 1 thatuses the cyanide. According to rule 91 all such events should berecorded as an eRecord and executed only upon obtaining approval of twoindividuals: James Dunn and Mark Arthur. According to rule 92, allevents occurring at Plant 1 should generate an eRecord for recording butunless other conditions are also met, e.g., the event includes cyanide,an eSignature is not necessary. If an eSignature is not required, usersare not prompted to sign the transaction and in typical cases, the enduser is shown a message that indicates the transaction is complete.

Electronic Record and Electronic Signature Processing

In operation, ERES framework engine 22 responds to events generated bybusiness application 36 or other business transaction logic to createelectronic records, collect electronic signatures and store electronicrecords and signatures in evidence store 30 as appropriate. ERES engine22 can assign each instance of an event (each time the event istriggered) a unique event key that system 10 uses to track eRecord dataassociated with the particular event instance. The unique key can bepassed as a parameter to an API that raised the event.

Referring again to FIG. 3, the blocks within ERES engine 22 representmethod steps performed by engine 22 in response to the triggering of abusiness event 40 by a business application 36 that results ingeneration of an eRecord to be stored in the evidence store. In oneembodiment, the event trigger process results in business application 36calling an API that initiates a work flow process. The API may include,for example, the event name and an event ID, an indication of whetherdeferred signature collection mode is allowed for an event or not, thebusiness application that the event was raised from, a username of aperson that raised the event and any API or function that should beinvoked by system 10 after the completion of the event among otherinformation. The initiated work flow process is then run by the ERESengine.

As shown in FIG. 3, the ERES engine creates an eRecord in response tothe trigger event (step 80). The eRecords are based upon the DTDs 42 andXML mappings 43 prepared under the guidance of eRecord content setupcomponent 42 for the event. In one embodiment, upon creation, individualeRecords are stored in a database table that includes the XML datagenerated from mappings 43 as the mapped data existed at creation time,a copy of the XML data as it is displayed to users in the associated XSLstyle sheet, a primary key that is unique to each eRecord created insystem 10, various time entries such as the timestamp when the eRecordwas requested, the time stamp creation of the eRecord was initiated, thetime zone the eRecord was created in, the status of the eRecord (e.g.,pending, complete, error), the name of the entity or agent thatrequested creation of the eRecord, the event that the eRecord wascreated for and a field that tracks the number of times the eRecord wasprinted or viewed.

If a particular event requires an eSignature, ERES framework engine 22evokes the appropriate signature collection rule 45 created undereSignature collection rule setup component 20 c and instantiates aprocess to collect approval signatures according to the approval matrix46 (step 81) associated with the rule. The instantiated process routes anotification that a signature is needed to each necessary approver (step82). In one embodiment a record of each eSignature requested is storedin evidence store 30 in a database table that includes a primary key ofa signature ID, a document ID that links the signature record to theeRecord (e.g., the primary key of the eRecord), the name of the user(signee) being asked to sign the eRecord, the signee's response, thedate and time the eRecord was signed, the time zone that it was signedin and the status of the eSignature (e.g., pending, complete, rejected,error).

The notification of the eSignature request can be routed by, forexample, email or a pop-up window. In either case, the requested signeeis asked to review information associated with the eRecord 80 beforegranting approval or rejecting the request. The information presented tothe signee is formatted according to the style sheet 44 that was createdfor such purpose (step 83). Once an eRecord has been completed andsigned by each necessary signee, ERES engine 22 verifies the electronicsignature and changes the status of the eSignature request to “complete”(step 84). Signature verification can be done, for example, by executinga function in the background to determine if all signatures have beenobtained and comparing the captured username and password pair for eachsignature to the system's valid username/password pairs stored indatabase 34.

Events raised by business application 36 that create eRecords typicallyalso result in an update to one or more of the tables of database 34that tracks data associated with the business application. In this sensethe business event can be thought of as initiating a transaction thatmay or may not get completed. Records of the transaction are stored inthe evidence store regardless of whether or not the transaction iscompleted. i.e., the evidence store provides a complete history of abusiness event including failed or incomplete events. If the transactioninitiated by the event is successfully completed, however, details ofthe transaction are committed to database 34. The actual transactiondata that is updated in database 34 will vary according to the actioninitiated by the business application.

As one example, consider a scenario in which a trigger event is definedin one business application to generate an eRecord and an eSignaturerequest in response to the creation of a purchase order (the purchaseorder is the transaction). Thus, when a user select a “create purchaseorder” option in this particular business application, an eRecord isautomatically generated and a work flow process is initiated to capturethe appropriate signature to authorize the purchase order. Upon itscreation, the eRecord is stored in evidence store 30 with all thevarious fields of the purchase order completed according to the datathat was captured in the eRecord from the mappings 43. The eSignaturecollection process is then started. The signature collection processdisplays the purchase order with the captured data according to apredefined XSL style sheet to each signee. The eRecord stored inevidence store 30 stores the captured data in XML format and also storesthe data as formatted in the eSignature request.

If authorization for the purchase order is approved by all necessarysignees, each signee field in the eRecord in evidence store 30 isupdated as “complete” and the purchase order is committed againstdatabase 34, i.e., the business transaction is completed. Ifauthorization is denied by a signee with appropriate authority, theeRecord in evidence store 30 is updated to indicate which signee“rejected” the purchase order and the purchase order is not committedagainst database 34. This may require rolling back some portions of thepurchase order transaction process that updated one or more portions ofappropriate tables in database 34 so that database 34 is in the samestate it was in prior to the purchase order request. In such a case,evidence store 30, however, will store all the necessary informationthat indicates a particular purchase order was created, authorizationfor the purchase order was obtained and ultimately denied by aparticular individual.

In another example, the purchase order may include one or more fieldsthat require data entered by a user through an electronic form-baseddata entry process. In such a form-based process, the eSignature requestis not initiated until the user completes entry of data in the form andselects an icon such as “obtain authorization”. At that time, theeRecord includes the data entered by the user along with any other datacaptured from database 34 that is part of the eRecord. For example, theautomatically captured data may include information such as a customername and a shipping address and the data entered via an electronic formmay include a product code and a quantity indicated. The eRecord willstore the purchase order in XML format including the captured customername and shipping address and the entered product code and quantity.

After an event has been completed, system 10 next invokes the API thatwas identified in the original event API call, if an API was designated,for post-ERES processing. All eRecords generated and placed in evidencestore 30 are committed to the evidence store 30 permanently, i.e., noeRecord can be deleted from the evidence store tables in the ordinarycourse of business. Also, the XML data captured in each eRecord iscaptured as a permanent record that also cannot be changed in theordinary course of business.

Electronic Record and Electronic Security Model

As indicated above, the eRecords stored in evidence store 30 are arepository of very critical information for a company that often needsto be queried for various reasons ranging from internal users perusingthe information to regulatory authorities inspecting process records.The information contained in these records can be confidential andcritical to the nature of the business. Accordingly, embodiments of theinvention allow a company to restrict access to eRecords to prevent anyunauthorized access. Such security controls are defined and performed bysecurity rule engine 24.

Security rule engine 24 allows users to identify and tag secure XML datarecords within evidence store 30, create security rules and, for usershaving the appropriate security privileges, turn selected securityfeatures of system 10 ON and OFF. Security rule engine 24 also providessecurity mechanisms to ensure that eRecords can never be removed fromevidence store 30 and that electronic signatures cannot be excised,copied or otherwise transferred to falsify an electronic record byordinary means. In some embodiments, security rule engine 24 alsointerfaces query engine 26 to evidence store 30 to ensure that querieson the evidence store do not take place if any active security ruleindicates the user initiating the query does not have the necessaryaccess rights.

Security rule engine 24 restricts access contingent on the content of aneRecord and the event for which the eRecord was created. For example, ifa number of eRecords are created for a Lot Creation event, a responsibleuser (e.g., a Security Administrator) should be able to grant access toLot Creation eRecords with particular lot numbers to individual users orgroups of individual users. Engine 24 can be configured to operate inone of two modes: restrict mode in which access to eRecords is grantedby default and users or responsibilities can be restricted as requiredand grant mode where access to eRecords is restricted by default andusers or group basis based upon responsibilities assigned to the groupare granted access to specific records based on the values or datacontained in the record. Security rule engine 24 then allows securityrules that grant or restrict access to secured content to be created onan individual basis or responsibilities.

The eRecords stored in evidence store 30 are XML documents adhering toparticular DTDs defined by users of system 10. Before a security rulecan be created using a particular XML element, the element has to beidentified as a “secure element” (FIG. 3, function 90). A secure elementis essentially an XML element identified in a particular DTD with aspecial use of being able to create security rules. Security rule engine24 allows users to identify secure elements via a graphical userinterface (GUI). In one embodiment, the first step in identifying asecure element is to select the element as an indexed element or an“IXE”. Once an element is indexed, security rules and queries (discussedbelow) can be created for it.

System 10 can track indexed elements by setting an appropriate Booleanflag as an attribute of the element. That is, an element is eitherindexed or not indexed. In another embodiment the indexing of elementscan be tracked by a character field that can have one of two values:e.g., I for indexed, N for not indexed. The default value for eachelement upon creation of a DTD is “not indexed”. This default can bechanged by a user using the GUI.

FIG. 7 illustrates one example of a screen shot (computer display page100) from a GUI that can be employed to select elements to be indexed.As shown in page 100, XML elements can be searched on the basis of theelement name (field 101) or their display name (field 102). A user alsohas the option of displaying all elements in system 10 that are capableof being indexed, all elements that are already indexed or all elementsthat are not indexed by selecting an appropriate choice in field 103.The results of the user's search are displayed in area 104.

Using icon 105 or field 106, a user can select to create an IXE orupdate the attributes of an element presented in results area 104 sothat its attributes can be changed to an IXE or changed from an IXE to anon-indexed element. An example of an IXE creation screen shot (displaypage 110) is shown in FIG. 8. As shown in FIG. 8, page 110 includesselection boxes 111 and 112 that allow the user to designate uses forthe IXE including whether the IXE is used for security purposes (asecure element), query purposes (a query element) or both (a secure anda query element). Page 110 also includes a field 113 for assigning theIXE a user-friendly name that will appear to users when the IXE is usedto create a security rule or in a query.

System 10 creates a domain index (shown in FIG. 1B as index 33) from theindexed elements, or updates the existing domain index, by, for example,selecting apply icon 114 shown in FIG. 8. Index 33 facilitatesidentifying records containing the elements in the evidence store andincludes separate sections that are defined for each indexed element. Inone embodiment, index 33 is created using Oracle's interMedia Textproduct and stored in the internal tables of database 34.

FIG. 9 illustrates one example of database tables that can be used totrack indexed elements as part of index 33. Shown in FIG. 9 are threeseparate tables: table 33 a which is used to store indexed elements foreRecords, table 33 b which is the translation table for the indexedelements and table 33 c which is used to store the usage of an indexedelement. As shown in FIG. 9, each of tables 33 a-33 c include variousaudit columns that track when an element was created, who created it,etc. Table 33 a also includes a indexed element primary key(element_id), a field that map the indexed element to an XML element ina particular DTD, fields that identify the entry in the index (section)for the indexed element as well as the unique tag associated with theentry and a field that tracks whether the indexed element is indeedindexed. Table 33 b contains a field that matches the element_id to adisplay name that can be easily digested by a user and a field thattracks a description of the element. Finally, table 33 c tracks theusage of the indexed element as a query element or secure element asdiscussed further below.

An element chosen to be an IXE is either a generic IXE or a DTD-specificIXE. A generic IXE is an IXE that is applicable to all eRecords inevidence store 30 irrespective of the DTDs. A DTD-specific IXE is an IXEthat is applicable to eRecords based only on a particular DTD. This isthe case when, for example, the same XML element has different semanticsassociated with it across different DTDs. Once an element is indexed anddesignated as a secure element, engine 22 allows users to createsecurity rules with the element (FIG. 3, function 91).

A security rule creates a restriction or provides a grant similar to:

-   -   “Allow user James (user id: JASDE) to access eRecords for the        event Formula Approval having value Yeast for Formula        Ingredient”        where “Formula Ingredient” is the secure element for the event        “Formula Approval” and access to value “Yeast” is being granted        to user id “JASDE”. Similarly, access to a particular user can        also be restricted for a specific value. Engine 22 also allows        security rules to be established for groups of users having        common responsibilities or privileges. For example:    -   “Allow responsibility Manager to access all eRecords for the        event Employee Creation having value Salary for Employee Detail”

Using such security rules, access to the eRecords for specific eventscan be restricted based on the contents of the eRecords; specificallythe value of the secure elements in the eRecord. In addition to allowingusers and responsibilities access or restricting such access based on aneRecord's content, engine 22 allows a group of users to be grantedaccess to eRecords while restricting particular users within the groupto the records based on their content and it allows a group of users tobe restricted from accessing eRecords while allowing particularindividuals within the group to be granted such access based on therecord's content.

Security elements can be searched for in a manner similar to thatdescribed for indexed elements. FIG. 10 illustrates one example of ascreen shot (computer display page 120) from a GUI that can be employedto find already defined security elements. As shown in page 120,security elements can be searched on the basis of the element name(field 121), event name (field 122) and either user (field 123) orresponsibility (field 124). The results of the search (security rulescreated for the security element) are displayed in area 125.

As shown in FIG. 10, each security rule has a start date and an enddate. This allows a user a lot of flexibility in enabling or disablingsecurity rules without having to delete them or re-create them. Asecurity rule can be deleted by selecting the trash icon 126 for therule and a new security rule can be created by selecting create securityrule icon 127.

FIG. 11 shows one example of a table 33d used to track security rulescreated according to some embodiments of the invention. Table 33dincludes a primary key (rule_id), a field that references the securityelement (element_id) upon which the rule operates, various fields fortracking the parameters of the rule and audit columns that track whocreated the rule, when it was created and modified, etc.

An example of a security rule creation screen shot (display page 130) isshown in FIG. 12. As shown in FIG. 12, page 130 displays the name of thesecure element for which the rule is being created (field 131), theevent name (field 132) and allows a user to enter a value in field 133that, if present in an eRecord, will result in the security condition(grant or restrict) as entered by the user in field 136 being applied tothe record. The user creating the rule is preferably aware of whethersecurity rule engine 24 has been set to operate in high security mode(default of restricting access to all eRecords unless a rule explicitlygrants a user/responsibility access to the record) or low security mode(default of granting access to all eRecords unless a rule explicitlyrestricts a user/responsibility from accessing record).

Table 1 below lists five exemplary rules and the effect such rules haveif engine 24 is set to operate in high security default mode.

TABLE 1 Examples of Rules vs. Effect in High Security Mode Rule No.Security Rule Effect 1 Grant access to user U1 for None. Access alreadygranted. formula change eRecords having dry yeast. 2 Grant access toresponsibility R1 None. Access already granted. for formula changeeRecords having dry yeast. 3 Restrict access to responsibility R1 Accessfor R1 restricted. for formula change eRecords having dry yeast. 4Restrict access to user U1 for Access for U1 restricted. formula changeeRecords having dry yeast. 5 1 + 3 Access for U1 granted but rest of R1restricted.As evident from the Table 1, creating either rules 1 or 2 does not makemuch sense as the rules do not have any effect.

Table 2 below lists five exemplary rules and the effect such rules haveif engine 24 is set to operate in low security mode.

TABLE 2 Examples of Rules vs. Effect in Low Security Mode Rule No.Security Rule Effect 1 Grant access to user U1 for Access granted to U1.formula change eRecords having dry yeast. 2 Grant access toresponsibility R1 Access granted to U1. for formula change eRecordshaving dry yeast. 3 Restrict access to responsibility R1 None. Accessalready for formula change eRecords restricted. having dry yeast. 4Restrict access to user U1 for None. Access already formula changeeRecords having restricted. dry yeast. 5 2 + 4 Access for U1 granted butrest of R1 restricted.As evident from Table 2, creating rules 3 and 4 when engine 24 operatesin low security mode does not make much sense because those rules haveno added effect.

Referring to FIG. 12 again, the user or responsibility that the rulerestricts or grants access to eRecord for can be identified in fields134 and 135, respectively. Finally, start and ending dates for the rulecan be entered in fields 137 and 138. If no end date is entered, therule will be in effect for perpetuity. If no specific start date isentered, the rule will take effect immediately (e.g., the current datewill be entered by default).

A user with appropriate system level privileges can use security ruleengine 24 to enable and disable the security features (FIG. 3, function92). In one embodiment, when security is enabled queries are modifiedusing the defined security rules before running the queries against theevidence store. Referring to FIG. 3, queries can be created by users 12working with query engine 26 and user interface 32 in the mannerexplained below. Once a specific query 95 is created and selected to beexecuted against the evidence store, security engine 24 determines ifthere are any security rules that are relevant to the query. If thereare, the query is dynamically modified by security rule engine 24 basedon the defined security rules that are relevant to the query to create amodified query 96. The modified query is then executed against theevidence store and the results are returned to the user. If there are norelevant security rules, the original query (query 95) is run againstthe evidence store. In one embodiment the determination on whether ornot to create a modified query 96 is made by identifying the indexedelements within original query 95 and identifying secure elementscreated from the indexed elements. A modified query 96 is generated ifany secure elements have been created from the same indexed elementsused in query 95.

In one embodiment, virtual private database (VPD) technology availablefrom Oracle Corp., the assignee of the present application, is used todynamically modify each query using the defined security rules prior torunning the query against the evidence store. Oracle's VPD technologyallows security engine 24 to modify SQL query statements based on aWHERE condition (known as a predicate) returned by a function thatimplements the security policy. The SQL statement is modifieddynamically in a manner transparent to the user using any conditionwhich can be expressed in, or returned by, a function.

As an example of one embodiment of the invention where evidence store 30evidence store 30 stores eRecords having XML data that include separatefield INGREDIENT and DEV_STAGE consider a query generated by a user toidentify all eRecords in pertain to ingredient “sugar” where a securityrule exists that prevents eRecords associated with a “clinical stage” ofthe development process from being accessed. The original SQL format forsuch a query may be represented as:

-   -   select document_id    -   from edr_psig_documents    -   where contains (psig_xml, ‘sugar within INGREDIENT’)>0        where the eRecord is identified by its “document_id”,        “edr_psig_documents” is the name of the table in evidence store        30 that stores eRecords and “psig_xml” is the CLOB column of XML        data within the edr_psig_documents table. Security engine 24        modifies the original query by converting the security rule into        a predicate that is AND'd with the original predicate of the SQL        statement. The modified query may then be represented as:    -   select document_id    -   from edr_psig_documents    -   where contains (psig_xml, ‘sugar within INGREDIENT’)>0    -   and contains (psig_xml, ‘clinical_stage’ within DEV_STAGE’)+0=0        where the second contains clause was added by security engine        24.

As evident from the above described indexing process, a lot offlexibility is provided that allows different semantics to be associatedwith the same XML element or the same semantics to be associated withdifferent elements. This in turn allows organizations to exercise atremendous amount of flexibility in securing eRecords to obtaininformation from data. As an example of this flexibility, consider thefollowing scenario. A user identifies that XML element ITEM_NO in aparticular eRecord for an Item Creation event refers to anidentification number of a particular class of items and creates asecure element called Item Number using ITEM_NO for these records. Theuser can also identify that XML element FORMULA_INGREDIENT in an eRecordthat conforms to a different DTD for a Formula Creation event alsoactually refers to the same class of identification numbers as in theprevious eRecord. The user can then create a secure element called ItemNumber using FORMULA_INGREDIENT for these records and thereby linkcertain security rules defined by the user on the Item Number secureelement to both types of eRecords. The user can also identify that theXML element ITEM_NO in a completely different set of eRecords adheringto a third DTD actually means something entirely different, such as acontract term in a Procurement Contract event. The user can then goahead and create a secure element called Contract Term using the ITEM_NOelement for these eRecords. Based on this scenario, a user can thencreate a security rule that, for example, restricts access to user “Neo”for all eRecords that include the secure element Item Number having avalue of 057. This rule would then secure such eRecords generated fromItem Creation and Formula Creation events but would not secure eRecordsgenerated from a Procurement Contract event.

Electronic Record and Electronic Query Engine

The eRecords stored in evidence store 30 often need to be queried forvarious reasons ranging from internal users perusing the information toregulatory authorities inspecting process records. Query engine 26allows users to identify XML elements upon which queries and searchesare to be performed and allows users to generate and execute queriesbased on the identified elements. To perform such queries, however, auser needs to be able to distinguish fields in different DTDs defined bythe users in step 62 (FIG. 4) that have identical XML field names yetrepresent different pieces of data. For example, evidence store 30 mayinclude many different electronic records that have an XML documentidentifying an “item number” that is part of the record. The “itemnumber” in each XML document may adhere to different DTDs, however, andthus may refer to completely different item lists where a particularnumber equates to different items in the different DTDs.

As an example, in one DTD (DTD 1) that defines the ingredients for drugX, “item number” may be the unique identifier of each ingredient used tomanufacture the drug. In another DTD (DTD 2) that defines the results ofa comprehensive drug study, “item number” may be a unique identifierthat identifies which drug or placebo was given to a patient. Thus, itemnumber 003 in DTD 1 may be “glycerin” while item number 003 in DTD 2 maybe “placebo”. Accordingly, a query in evidence store 30 for all recordsthat involve “glycerin” needs to be able to do more than search for anitem number of 003.

Embodiments of the invention allow users to use query engine 26 toidentify the XML elements of each DTD used to generate an eRecord thatcan be queried within evidence store 30. As an initial step in definingquery elements, the element has to be indexed as described above withrespect to security rule engine 24. The indexing process builds a domainindex (FIG. 1, index 33) on top of the tables that make up evidencestore 30 as described above. The indexed elements can be designated asquery elements (FIG. 3, function 93) using the process also describedabove and used in queries. This process provides the same flexibility inusing query elements that was described above with respect to secureelements.

In one embodiment, queries elements can be created under the guidance ofa GUI using a display page 140 such as that shown in FIG. 13. As shownin FIG. 13, the query creation page 140 is divided into two sections: atop section 141 allows a user to specify query criteria and a bottomsection 142 displays the results of a given query. In top portion 141, auser can select between a simple query (tab 143 or an advanced query(tab 144). The query options in a simple query include event name (field145), a date range (fields 146, 147) and a user id of an eRecord signer(filed 148). Such queries can be run by selecting find icon 149.

Bottom portion 142 of screen 140 displays header level information fromeRecords matching the query criteria including the business event name(field 150), the unique identifier of the event (field 151) andtime-related information (fields 152, 153). If desired A user can selectto print individual ones of the eRecords by clicking on print selectionboxes 154.

An example of an advanced query screen page 160 is shown in FIG. 13.Page 160 allows a user to directly query the XML format of eRecords byallowing a user to select specific XML elements in fields 161 and enterparticular values to be searched in field 163. Condition field 162allows the user to select whether the query is for records that equalthe value chosen in field 163, for records having a value less than thechosen value, for records having a value greater than the chosen value,etc. Additionally, a user can include multiple selection criteria in asingle query by adding another row to the query and selecting whetherthe row is to be logically AND'd or OR'd (field 164) with the previouscriteria. The advanced query page returns query results to an area 165that is similar to area 142 shown in FIG. 12 screen. Details ofindividual eRecords can be displayed from either of query resultssections 142 or 165 by clicking on an appropriate selection box 155 or166, respectively.

Once a query is created (FIG. 3, query 95) it can then be executedagainst the evidence store (FIG. 3, function 94). Before doing so,however, the query is modified based on the security rules (FIG. 3,modified query 96) as explained in detail above. The modified query isthen executed against evidence store 30 only if it does not violate anyof the security rules.

Example of Query Capabilities and Security Measures Provided byInvention

FIGS. 15-21 further illustrate the capabilities and functionality thatcan be obtained using some embodiments of the invention. Specifically,FIGS. 15-21 represent exemplary screen shots and data formats that arecreated by system 10 in order to implement a scenario where a companythat controls a manufacturing application that requires the creation of‘items’ and ‘lots’ containing those items. The company desires that datafor business transactions resulting in the creation of either of thesetwo entities be captured as eRecords and stored in evidence store 30.Each eRecords includes a well-formed XML document stored in a singlecolumn (column name) of a table (table name) in evidence store 30.

In this exemplary scenario, a transaction that results in the creationof an item is referred to as an ‘Item Creation’ event and a transactionthat results in the creation of a lot is referred to as a “Lot Creation’event. Thus, eRecord are created for both Item Creation and Lot Creationevents whenever such events take place. The XML documents (eRecords)that are created for each of these events adhere to different DTDs,however, as defined by a user using data setup component 20. In thisscenario, the predefined DTDs for both Item Creation and Lot Creationevents include an XML element labeled “ITEM_NO”. While this XML elementfunctionally refers to an item number because of the way the DTDs aredefined, in the case of an Item Creation event, end users identify theitem number with an ‘item’ while in the case of a Lot Creation event endusers identify the item number as a lot item as shown in FIGS. 15 and16, which are screen shots showing the creation of indexed elements thatcan be used as both query and secure elements from each XML element by auser. FIG. 17 is a screen shot that demonstrates the XML element‘item_no’ is associated with two different indexed elements aftercreation of the indexed elements as shown in FIGS. 15 and 16.

Once the set up of the indexed, query and secure elements is complete,queries using query elements and security rules using secure elementscan be created. FIG. 18 is a screen shot 170 illustrating one example ofa query that can be created and executed on the data. As shown in FIG.18, a query can be generated by entering a query element in field 171and a value in field 172. Query elements can be selected in field 171from a list of query elements presented in drop down menu format whenfind icon 173 is selected. In FIG. 18 a user has created a query thatwill return all eRecords that include a ‘lot item” (previously definedas XML element ‘item_no’ in a Lot Creation event per FIG. 14) that has avalue of 4101. The results of the query are shown in area 174. FIG. 19is another screen shot 180 illustrating another example of a query thatcan be created and executed on the data. As shown in FIG. 19, a user hascreated a query that will return all eRecords that include an “item”(previously defined as XML element ‘item_no’ in an Item Creation eventper FIG. 13) that has a value of 4101. The results of the query areshown in area 184. As evident from a comparison between FIGS. 18 and 19,each query only returned results where the XML element ‘item_no’ equaled4101 for the DTD the query element is associated with. The XMLelement(s) that have the same value but that are associated with adifferent DTD were not returned.

Referring now to FIG. 20, which is an exemplary screen shot illustratingthe creation of a security rule that restricts user CSingh fromaccessing all eRecords where the secure element ‘item’ (previouslydefined as XML element ‘item_no in an Item Creation event per FIG. 13)has a value 4101. When the same query created in FIG. 19 is now executedon the evidence store by user CSingh, no eRecords are returned as shownin FIG. 21 because the security rule created in FIG. 20 prevents CSinghfrom viewing the eRecords. If user CSingh ran the query shown in FIG.18, however, the results would be identical to those shown in FIG. 18because the security rule created in FIG. 20 only applies to “item”elements and does not apply to “lot item” elements.

Having fully described several embodiments of the present invention,other equivalent or alternative methods of practicing the presentinvention will be apparent to those skilled in the art. For example,while system 10 was described as a distributed system, the system may bedeployed in various other environments such as an enterpriseenvironment, a stand-alone system, and the like. Also, while the presentinvention has been described using a particular combination of hardwareand software, it should be recognized that other combinations ofhardware and software are also within the scope of the invention.Specifically, the invention may be implemented primarily in hardware,primarily in software, or using appropriate combinations thereof.

As another example, evidence store 30 was described as containingunstructured data in the form of XML documents. Embodiments of theinvention can be used to access other types of unstructured data storedin the evidence store including, for example, data stored in othermarkup language formats. These and other embodiments as well asalternatives and equivalents to the invention will be recognizable tothose of skill in the art after reading the description of the presentinvention. The scope of the invention should not, therefore, bedetermined solely by reference to the above description, but insteadshould be determined with reference to the appended claims along withtheir full scope of equivalents and alternatives.

1. A computer-implemented method of associating an electronic signaturewith an electronic record, the method comprising: receiving, at acomputer system configured to manage a database of electronic records,first information provided by a user via a graphical user interfaceconfigured to enable users of the computer system to define operationsby one or more database applications as triggering conditions forapplication events monitored by the computer system and processing thatoccurs when the application events are triggered, the first informationdefining an application event that, upon occurrence, causes the computersystem to intercept a database transaction instantiated by one of thedatabase applications with a database management system of a databaseand generate from data identified in the database transaction anelectronic record that requires an electronic signature; receiving, atthe computer system, second information provided by the user via thegraphical user interface, the second information defining one or morefields for data to be stored in the electronic record; receiving, at thecomputer system, third information provided by the user via thegraphical user interface, the third information providing a mappingbetween data from underlying database tables associated with thedatabase transaction to at least some of the fields defined for data tobe stored in the electronic record; receiving, at the computer system,fourth information provided by the user via the graphical userinterface, the fourth information defining a layout that is applicablewhen an electronic signature is collected for the electronic record fordisplaying data stored in the electronic record on a computer display;receiving, at the computer system, fifth information provided by theuser via the graphical user interface, the fifth information identifyinga signatory approver for the electronic record; in response to detectingthe occurrence of the application event at the computer system when theone of the database applications instantiates the database transactionassociated with the application event with the database managementsystem of a database, automatically generating the electronic recordwith the computer system from data intercepted from the databasetransaction according to the mapping between the data from theunderlying database tables associated with the database transaction tothe at least some of the fields in the electronic record; displaying theelectronic record using the computer system to the signatory approveraccording to the defined layout in order to collect an electronicsignature for the electronic record; receiving, at the computer system,an electronic signature from the signatory approver for the electronicrecord; and generating, by the computer system, sixth informationassociating the electronic signature from the signatory approver withthe electronic record prior to performing an action with the computersystem that results in committing the database transaction to thedatabase associated with the database management system.
 2. The methodof claim 1 further comprising verifying the electronic signature at thecomputer system prior to associating the electronic signature with theelectronic record.
 3. The method of claim 2 wherein associating theelectronic signature with the electronic record comprise associating bythe computer system the electronic signature with the electronic recordin response to a positive verification of the electronic signature. 4.The method of claim 1 wherein the electronic signature comprises a userid and a password.
 5. The method of claim 1 further comprising verifyingthe electronic signature by the computer system and storing theelectronic record with the computer system in a common repository ofelectronic records that are generated from multiple data sources.
 6. Themethod of claim 5 wherein the electronic record comprises unstructureddata in a character large object (CLOB) format.
 7. The method of claim 6wherein the common repository is a database and wherein the unstructureddata is a well-formed XML document stored within a column of a tablestored in the database.
 8. The method of claim 1 further comprising:receiving, at the computer system, seventh information provided by theuser via the graphical user interface, the seventh informationspecifying a set of business rules associated with the applicationevent; determining, with the computer system, a business rule from theset of business rules associated with the application event; andexecuting the business rule with the computer system to determinewhether an electronic signature is required to connote review orapproval of the electronic record.
 9. A computer system that manages adatabase of electronic records, the computer system comprising: aprocessor; and a computer-readable memory coupled to the processor, thecomputer-readable memory configured to store a computer program; whereinthe processor is operative with the computer program to: (i) receivefirst information provided by a user via a graphical user interfaceconfigured to enable users of the graphical user interface to defineoperations by one or more database applications as triggering conditionsfor application events and processing that occurs when the applicationevents are triggered, the first information defining an applicationevent that, upon occurrence, causes the processor to intercept adatabase transaction instantiated by one of the database applicationswith a database management system of a database and generate from dataidentified in the database transaction an electronic record thatrequires an electronic signature; (ii) receive second informationprovided by the user via the graphical user interface, the secondinformation defining one or more fields for data to be stored in theelectronic record; (iii) receive third information provided by the uservia the graphical user interface, the third information providing amapping between data from underlying database tables associated with thedatabase transaction to at least some of the fields defined for theelectronic record; (iv) receive fourth information provided by the uservia the user interface, the fourth information defining a layout that isapplicable when an electronic signature is collected for the electronicrecord for displaying data stored in the electronic record on a computerdisplay; (v) receive fifth information provided by the user via thegraphical user interface, the fifth information identifying a signatoryapprover for the electronic record; (vi) intercept data from thedatabase transaction instantiated by the one of the databaseapplications with the database management system of a database togenerate the electronic record in response to detecting the occurrenceof the application event, the electronic record generated by theprocessor according to the mapping between the data from the underlyingdatabase tables associated with the database transaction to the at leastsome of the fields in the electronic record; (vii) receive an electronicsignature from the signatory approver for the electronic record; and(viii) generate sixth information that associates the electronicsignature from the signature approver with the electronic record priorto performing an action committing the database transaction instantiatedby the one of the database applications with the database managementsystem of a database to the database associated with the databasemanagement system.
 10. The computer system of claim 9 wherein processoris further operative to verify the electronic signature.
 11. Thecomputer system of claim 10 wherein processor is operative to associatethe electronic signature with the electronic record in response to apositive verification of the electronic signature.
 12. The computersystem of claim 9 wherein the electronic signature comprises a user idand a password.
 13. The computer system of claim 12 wherein theprocessor is further operative to verify the electronic signature andstore the electronic record in a common repository of electronic recordsthat are generated from multiple data sources.
 14. The computer systemof claim 13 wherein the electronic record comprises unstructured data ina character large object (CLOB) format.
 15. The computer system of claim14 wherein the common repository is a database and wherein theunstructured data is a well-formed XML document stored within a columnof a table stored in the database.
 16. The computer system of claim 9wherein the processor is further operative to: determine a business rulefrom a set of business rules associated with the application event; andexecute the business rule to determine whether an electronic signatureis required to connote review or approval of the electronic record. 17.A computer program product embodied on a computer-readable storagemedium configured to store a set of code modules which when executed bya processor of a computer system cause the processor to manage adatabase of electronic records, the computer program product comprising:code for displaying a graphical user interface configured to enableusers of the graphical user interface to define operations in one ormore database applications as triggering conditions for applicationevents and processing that occurs when the application events aretriggered; code for receiving first information provided by a user viathe graphical user interface, the first information defining anapplication event that, upon occurrence, causes a database transactioninstantiated by one of the database applications with a databasemanagement system of a database to be intercepted and an electronicrecord that requires an electronic signature to be generated from dataidentified in the database transaction; code for receiving secondinformation provided by the user via the graphical user interface, thesecond information defining one or more fields for data to be stored inthe electronic record; code for receiving third information provided bythe user via the graphical user interface, the third informationproviding a mapping between data from underlying database tablesassociated with the database transaction to at least some of the fieldsdefined for data to be stored in the electronic record; code forreceiving fourth information provided by the user via the graphical userinterface, the fourth information defining a layout that is applicablewhen an electronic signature is collected for the electronic record fordisplaying data stored in the electronic record on a computer display;code for receiving fifth information provided by the user via the userinterface, the fifth information identifying a signatory approver forthe electronic record; code for, in response to detecting the occurrenceof the application event when the one of the database applicationsinstantiates the database transaction with the database managementsystem of a database, generating the electronic record from dataintercepted from the database transaction according to the mappingbetween the data from the underlying database tables associated with thedatabase transaction to the at least some of the fields in theelectronic record; code for displaying the electronic record to thesignatory approver according to the defined layout in order to collectan electronic signature; code for receiving an electronic signature fromthe signatory approver for the electronic record; and code forgenerating sixth information associating the electronic signature fromthe signatory approver with the electronic record prior to performing anaction that results in committing the database transaction to thedatabase associated with the database management system.
 18. Thecomputer program product of claim 17 further comprising code forverifying the electronic signature.
 19. The computer program product ofclaim 18 wherein the electronic signature comprises a user id and apassword.
 20. The computer program product of claim 18 furthercomprising code for storing the electronic record in a common repositoryof electronic records that are generated from multiple data sources. 21.The computer program product of claim 20 wherein the electronic recordcomprises unstructured data in a character large object (CLOB) format.22. The computer program product of claim 21 wherein the commonrepository is a database and wherein the unstructured data is awell-formed XML document stored within a column of a table stored in thedatabase.